Cleared Traditional

K911327 - CELL SWEEP

K911327 is an FDA 510(k) clearance for CELL SWEEP, manufactured by Reza S Mohajer, M.D. C/O Krass & Young. The device is a Class 2 Obstetrics & Gynecology device with product code HHT cleared through the Traditional 510(k) pathway after a 56-day FDA review.

K911327 · Reza S Mohajer, M.D. C/O Krass & Young · Obstetrics & Gynecology device
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May 1991
Decision
56d
Days
Class 2
Risk

K911327 is an FDA 510(k) clearance for the CELL SWEEP. Classified as Spatula, Cervical, Cytological (product code HHT), Class II - Special Controls.

Submitted by Reza S Mohajer, M.D. C/O Krass & Young (Troy, US). The FDA issued a Cleared decision on May 21, 1991 after a review of 56 days - a notably fast clearance cycle.

This device falls under the Obstetrics & Gynecology FDA review panel, regulated under 21 CFR 884.4530 - the FDA obstetrics and gynecology device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Reza S Mohajer, M.D. C/O Krass & Young devices

FDA 510(k) Submission Details - K911327

510(k) Number K911327 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 26, 1991
Decision Date May 21, 1991
Days to Decision 56 days
Submission Type Traditional
Review Panel Obstetrics & Gynecology (OB)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
104d faster than avg
Panel avg: 160d · This submission: 56d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

HHT Device Classification - Class 2, Special Controls

Product Code HHT Spatula, Cervical, Cytological
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 884.4530
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Obstetrics & Gynecology devices follow this clearance model.

Regulatory Peers - HHT Spatula, Cervical, Cytological

All 35
Devices cleared under the same product code (HHT) and FDA review panel - the closest regulatory comparables to K911327.
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WALLACH CC/BRUSH
K896065 · Wallach Surgical Devices, Inc. · Jan 1990
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K890013 · Kimberly-Clark Corp. · Apr 1989